Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Studieöversikt
Detaljerad beskrivning
This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet - B (NB-UVB).
Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB.
Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0).
Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC.
This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B.
Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP).
Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35205
- Total Skin and Beauty Dermatology Centers
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Dermatology Research of Arkansas
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California
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San Diego, California, Förenta staterna, 92123
- Therapeutics Clinical Research
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Florida
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Miami, Florida, Förenta staterna, 33136
- Florida Academic Dermatology Centers
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Georgia
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Atlanta, Georgia, Förenta staterna, 30327
- Peachtree Dermatology Associates
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46256
- Dawes Fretzin Clinical Research Group
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Massachusetts
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Andover, Massachusetts, Förenta staterna, 01810
- ORA Clinical Research and Development
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New York
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Bronx, New York, Förenta staterna, 10467
- Montifiore Medical Center
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New York, New York, Förenta staterna, 10016
- New York University School of Medicine
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New York, New York, Förenta staterna, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19103
- Paddington Testing Co.
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Rhode Island
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Johnston, Rhode Island, Förenta staterna, 02919
- Clinical Partners
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South Carolina
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Greer, South Carolina, Förenta staterna, 29651
- Radiant Research
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Texas
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Dallas, Texas, Förenta staterna, 75246
- Baylor Research Institute
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Dallas, Texas, Förenta staterna, 75230
- Dermatology Treatment & Research Center, PA Research
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Houston, Texas, Förenta staterna, 77058
- Center for Clinical Studies
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507
- Virginia Clinical Research, Inc.
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Washington
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Seattle, Washington, Förenta staterna, 98101
- Dermatology Associates
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Alberta
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Calgary, Alberta, Kanada, T2S 3B3
- Kirk Barber Research
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Edmonton, Alberta, Kanada, T5K 1X3
- Stratica Medical
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1Z4
- Eastern Canada Cutaneous Research Associates
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Ontario
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Hamilton, Ontario, Kanada, L8N 1V6
- Dermatrials Research
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Waterloo, Ontario, Kanada, N2J 1C4
- K.Papp Clinical Research Inc
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Quebec
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Montreal, Quebec, Kanada
- Siena Medical Research
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Quebec City, Quebec, Kanada, G1V 4X7
- Centre de Rescherche Dermatologique Du Quebec Metropolitain
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months
- Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy
Exclusion Criteria:
- Prior treatment with adalimumab
- Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies)
- Prior treatment with natalizumab
- Concurrent active skin diseases/infections
- Poorly controlled medical conditions
- History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
- History of certain cancers
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Öppna etikett
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Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0).
From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Tidsram: Week 16
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The PGA is a 6-point scale used to measure the severity of a patient's disease.
Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).
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Week 16
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants Achieving a PGA of Clear (0) at Week 16
Tidsram: Week 16
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Week 16
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Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
Tidsram: From Screening to Week 16
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From Screening to Week 16
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Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
Tidsram: Weeks 2, 4, and 8
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The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled.
0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.
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Weeks 2, 4, and 8
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Dermatology Life Quality Index (DLQI) Total Score
Tidsram: From Screening to Week 4 and Week 16
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The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10).
Participants rate how much their skin problem affected their life in previous week.
Responses are 0 (not at all) to 3=very much.
DLQI=total of scores for all items; max=30; min=0.
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From Screening to Week 4 and Week 16
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Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
Tidsram: Week 4 and Week 16
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DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.
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Week 4 and Week 16
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Psoriasis-related Pruritus Assessment
Tidsram: From Screening to Week 16
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The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching).
A decrease in score indicates an improvement in pruritus.
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From Screening to Week 16
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Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis
Tidsram: From Screening to Week 16
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The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be.
A decrease in score indicates improvement.
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From Screening to Week 16
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Percent Work Time Missed Due to Psoriasis
Tidsram: From Screening to Week 16
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Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work.
It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities.
Decreases in values on each part indicate improvement.
At Screening, percent time missed in the previous week ranged from 0% to 40%.
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From Screening to Week 16
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Percent Overall Work Impairment Due to Psoriasis
Tidsram: From Screening to Week 16
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Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above).
At Screening, overall impairment ranged from 0% to 94%.
A decrease in percent overall work impairment indicates improvement.
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From Screening to Week 16
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Percent Impairment While Working Due to Psoriasis
Tidsram: From Screening to Week 16
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Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above.
At Screening, impairment while working ranged from 0% to 90%.
A decrease in percent impairment indicates improvement.
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From Screening to Week 16
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Percent Activity Impairment Due to Psoriasis
Tidsram: From Screening to Week 16
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Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above.
At Screening, activity impairment due to psoriasis ranged from 0% to 90%.
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From Screening to Week 16
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Sleep Problems Index II
Tidsram: From Screening to Week 16
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Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache.
Participant rates each item from "none of the time" to "all of the time" for the previous 4 weeks.
Scores are transformed to 0 to 100 scale; lower scores indicate less impairment.
Decrease in score indicates improvement.
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From Screening to Week 16
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Martin M Okun, M.D., Ph.D., Abbott
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M10-238
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